Associate Director, Global Trial Lead | Remote / Home-Based (Global)
Job ID: R14705
Category: Development Operations / Clinical Trials
Job Type: Full-Time
Locations: Flexible / Remote – Global; office options in North America, Europe, Asia-Pacific
About Genmab
Genmab is a leading international biotechnology company committed to improving patient lives through innovative antibody therapeutics. For over 25 years, Genmab has developed next-generation antibody technology platforms, including bispecific T-cell engagers, antibody-drug conjugates, immune checkpoint modulators, and effector function-enhanced antibodies.
Headquartered in Copenhagen, Denmark, Genmab operates globally across North America, Europe, and Asia-Pacific. By 2030, the company aims to transform cancer treatment and serious diseases through its proprietary Knock-Your-Socks-Off (KYSO®) antibody medicines.
Learn more at www.genmab.com and follow Genmab on LinkedIn and X.
Role Overview
The Associate Director, Global Trial Lead (GTL) is responsible for the end-to-end delivery of clinical trials, from initial strategy through Clinical Study Report (CSR) completion. This role leads cross-functional Clinical Trial Teams (CTT), manages trial budgets, and aligns internal and external stakeholders to achieve trial objectives efficiently and to high-quality standards.
The GTL serves as the main coordinator for the trial team and may assume Clinical Trial Manager (CTM) responsibilities if a CTM is not assigned.
Key Responsibilities
Trial Leadership and Management
Lead cross-functional Clinical Trial Teams (CTT), including Medical, Biostatistics, Programming, and Data Management teams.
Manage operational trial teams including Start-up Specialists, Clinical Trial Associates (CTA), and CTMs.
Assign tasks, set goals, and ensure deadlines are met.
Make tactical decisions to align CTT activities with program objectives.
Provide regular progress updates, risk assessments, and escalations to leadership.
Review and approve trial documentation, including protocols, amendments, and manuals.
Oversee vendor selection, contracts, and trial-related agreements.
Coordinate country selection and responses to IEC/IRB comments.
Maintain trial integrity through protocol adherence and proactive issue resolution.
Budget, Planning, and Risk Management
Develop, manage, and monitor trial budgets.
Maintain integrated trial timelines from study outline to CSR delivery.
Develop patient recruitment projections and adjust strategies as needed.
Identify, monitor, and mitigate trial risks.
Oversee issue, action, and decision logs for effective risk management.
Support audits, inspections, and implement corrective and preventive actions (CAPAs).
Cross-Functional Collaboration
Partner with internal stakeholders, CROs, and external partners to drive alignment toward project goals.
Inform strategy and synopsis development in collaboration with Clinical Development Teams (CDTs).
Lead and participate in cross-functional working groups and process improvement initiatives.
Mentor and train team members on emerging clinical trial best practices.
Required Qualifications
Proven experience in global, complex, matrixed organizations.
Pharmaceutical industry experience with ICH-GCP knowledge and regulatory compliance expertise.
Oncology or therapeutic area-specific drug development experience across multiple phases.
Experience mentoring others and leading teams in a matrix leadership environment.
Strong knowledge of end-to-end trial planning, execution, and outsourcing/vendor management.
Excellent project management, budget management, and stakeholder engagement skills.
Effective communication, negotiation, and collaboration skills.
Experience managing multi-regional clinical trials and complex operations.
Preferred Qualifications
Proven track record in driving process improvements and efficient trial execution.
Strong understanding of regulatory submissions, audit readiness, and clinical trial systems.
Demonstrated ability to align diverse cross-functional teams toward trial objectives.
Compensation and Benefits (US-Based Candidates)
Base Salary Range: USD 148,320 – 222,480 annually, based on experience, qualifications, and location.
Eligibility for discretionary bonuses and long-term incentives.
Comprehensive health, dental, and vision coverage.
401(k) plan with company match.
Paid vacation, sick leave, holidays, and discretionary parental leave.
Wellness, financial planning, and lifestyle support resources.
About You
Passionate about advancing innovative therapies for patients with cancer and serious diseases.
Detail-oriented, precise, and committed to excellence in trial delivery.
Collaborative leader capable of guiding cross-functional teams in dynamic, global environments.
Experienced in fast-growing, matrixed organizations and adaptable to evolving priorities.
Committed to compliance, quality, and ethical standards in clinical research.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Bangkok |Israel :
Tel Aviv | Yavne | Be'Er Sheva | Netanya | Kfar Saba |Remote :
Green Way | Remote - Europe | Ireland | Thailand | Castlebar | Remote - Middle East | Texas | Nairobi | Bountiful | French | Zaragoza | Belgium | Lousiana | Manipal | Remote - Africa | Lenexa | McFarland | Remote - South America (Latin Americal) | Tulsa | Victoria | Hungary | Medan | Blue Bell | Remote | Leinster | Faridabad | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Springville | Riga | Hammond | Remote, USA | Slovakia | Switzerland | Melbourne | Xzagreb | Minnesota |Republic of Colombia :
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King Abdullah Economic City | Rabigh | Khulais | Najran | Riyadh | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Warsaw |